Propranolol for the Treatment of Infant Haemangiomas



Canberra Health ServicesClinical GuidelinePropranolol for the Treatment of Infant HaemangiomasContents TOC \h \z \t "Heading 1,1" Contents PAGEREF _Toc528574890 \h 1Guideline Statement PAGEREF _Toc528574891 \h 2Scope PAGEREF _Toc528574892 \h 2Section 1 – Indications for Treatment PAGEREF _Toc528574893 \h 3Section 2 – Propranolol PAGEREF _Toc528574894 \h 3Section 3 – Propranolol Initiation in Hospital (Inpatient Management) PAGEREF _Toc528574895 \h 5Section 4 – Medical follow up post discharge PAGEREF _Toc528574896 \h 6Implementation PAGEREF _Toc528574897 \h 7Related Policies, Procedures, Guidelines and Legislation PAGEREF _Toc528574898 \h 7References PAGEREF _Toc528574899 \h 8Definition of Terms PAGEREF _Toc528574900 \h 8Search Terms PAGEREF _Toc528574901 \h 8Guideline StatementThis document guides the treatment of infants with infantile haemangiomas with propranolol within the Canberra Health Services and the Centenary Hospital for Women and Children.BackgroundHaemangiomas are benign skin tumours comprised of proliferating vascular endothelial cells. Haemangiomas usually appear at, or shortly after birth and grow rapidly. They usually cease growing by 6 to 9 months of age, but may continue to grow until 18 months of age or more. Thereafter they slowly reduce in size and largely stop involuting by 5 years of age, sometimes leaving permanent residua such as telangiectasia, scarring or excess fibro-fatty tissue.For many haemangiomas, treatment is not required. However, haemangiomas in some locations require treatment to avoid complications such as ulceration, airway compromise, disruption of visual pathways etc. Haemangiomas with significant risk of deformity or psychosocial impact may also require treatment. In the short term, some parents may not interact normally with their infant despite adequate explanation about the expected natural history of involution. In the medium term, many untreated haemangiomas will still be visible at 3–8 years of age, and adverse psychosocial effects may develop before this age. In the long term, high‐risk areas for permanent visible deformity include lips, nose, cheeks and ears. Haemangiomas with a step‐edge or cobblestone surface also often leave permanent changes.Generally, the earlier that treatment is commenced, the more effective it will be at preventing long-term complications.Key ObjectiveTo limit proliferation of infant haemangiomas through use of propranolol.Alerts The guideline applies to infants up to the age of 18 months.Back to Table of ContentsScopeThis document applies to the following staff working within their scope of practice:Medical OfficersNursing staff Pharmacists.Back to Table of ContentsSection 1 – Indications for TreatmentHaemangiomas are treated to prevent ulceration, cosmetic disfigurement and adverse effects on vital organs. Those children who have haemangiomas with the following features should be considered for treatment:Life or function‐threatening infantile haemangiomasAirway haemangiomaPeriorbital or retrobulbar haemangioma at risk of causing visual impairment (risk of amblyopia from visual obstruction or pressure‐induced astigmatism)Spinal cord involvementHigh flow haemangioma with cardiac compromise – e.g. large hepatic lesionsHaemangiomas causing hypothyroidismLarge haemangiomas interfering with physical developmentSystemic haemangiomatosisUlcerated haemangiomas with significant painHaemangiomas at significant risk of ulcerationLipNappy areaFlexural areasHaemangiomas with significant risk of deformity and/or psychosocial impact e.g. affecting the lips, nose, cheeks or ears or large haemangiomas at other sites. Back to Table of Contents Section 2 – PropranololPropranolol is a non-selective beta adrenergic blocking agent. The mode of action in infantile haemangioma is not clearly defined, although propranolol is thought to reduce the size and stabilise growth by way of vasoconstriction, inhibition of vasculogenesis and decreased renin production.Risks and benefits of propranolol treatment should be discussed with the family. Benefits:Most effective treatment modalityLow risk medication (compared with other treatment modalities)Non-surgical approachRisks:Less serious: sleep disturbance, cold extremities, diarrhoeaSerious: bronchoconstriction, bradycardia, hypotension, hypoglycaemia (especially if reduced feeding secondary to illness)Relative contraindications:Consider seeking specialist advice in the following circumstances:Co-existing chronic lung disease or bronchospasmCardiac disease, including:persistent bradycardia <100 beats/min for infants under 3 months of age, or <90 beats/min for infants 3-6 months of ageCoarctation of the aortaIntercurrent illness causing reduced calorie intakeInfants prone to hypoglycaemia such as failure to thrive, concurrent or prior prednisolone therapy, poor feedingSuspected PHACE syndrome (see Definition of Terms) or other intracranial arterial anomaliesInitial Assessment:Cardiovascular examination (heart rate and femoral pulses in particular)ECG if abnormal cardiovascular examination, or if requestedOther investigations at the discretion of the managing clinician:Segmental head and neck haemangiomas may be associated with malformation of the eyes, heart, major arteries, and brain (PHACE syndrome). Consider an echocardiogram, MRI/MRA brain and neck, ophthalmology assessment.Segmental lumbar and pelvic haemangiomas may be associated with anogenital, renal or spinal anomalies. Consider ultrasound and MRI of the spine and renal ultrasound.Multiple haemangiomas may be associated with systemic haemangiomatosis. Consider a liver ultrasound and ultrasound or /MRI of the brain.Large infantile haemangiomas can be associated hypothyroidism and high output cardiac failure. Consider thyroid function testing and cardiac assessment/investigations if clinically appropriate.Standard propranolol dosing (oral):In healthy, thriving infants, oral propranolol can be commenced in an outpatient setting, with the first dose given at home.Week 1 – propranolol 1-2mg/kg/day in two divided doses (8-12 hours apart)(for example, a 3.4kg infant would receive 3.4 mg/day = 1.7mg per dose)Week 2 – propranolol 2mg/kg/day in two divided doses, unless a lower dose has been clinically effectiveIf the haemangioma responds well to treatment it may be unnecessary to increase the dosage of propranolol as the child's weight increases.If the response remains inadequate, consider increasing propranolol to 3mg/kg/day after discussing with a dermatologist. Propranolol AccessPropranolol should be supplied via Canberra Health ServicesCHS pharmacy on an in-hospital prescription, and prescribed in a concentration of 2mg/mL.Instructions for parents:Give propranolol dose during or after a feedIf the child is unwell or not feeding normally, do not give propranololIn the case of accidental overdose, seek medical help immediatelyIf your child develops a wheeze, do not give propranolol and contact your GP or treating doctorPropranolol may need to be discontinued for two (2) days prior to any planned surgery- discuss this your surgeon and anaesthetist prior to surgeryIf a dose of propranolol is accidentally missed, do not give an extra dosePatients for In-Hospital Commencement of PropranololConsider inpatient commencement of propranolol for the following patients:Very young infants (0-4 weeks of age corrected)Small for gestational age infantsWeight less than 2.5kg Those thought to be at particular risk for hypoglycaemiaBack to Table of Contents Section 3 – Propranolol Initiation in Hospital (Inpatient Management)Management in Paediatric Day Stay Unit (PDSU):Admit at 0900Baseline observationsWeek 1 Protocol: A lower initial dose is used for infants requiring inpatient commencement of propranolol, as they are at increased risk of hypoglycaemiaGive propranolol at 0.25mg/kg/dose during or just after a feed. The dose on discharge will usually be propranolol 0.5mg/kg/day in two or three divided doses, per consultant instruction. Paediatric RMO to write a hospital script for propranolol 2mg/ml concentration if not previously provided. This script is to be filled at the hospital pharmacy on discharge.Monitoring during admission:hourly heart rate for 3 hoursBlood Glucose Level (BGL) to be checked at 3 hours post dose by heel prickif observations and BGL are stable (>3.5 mmol/L), and the infant has fed, then discharge home.?If the BSL is 2.0-3.5, feed the infant and repeat the BGL after. If the BGL is <2, call a Medical Emergency (MET) and consider IV glucose or nasogastric (NG) feed if IV access is not quickly established. Week 2 Protocol: The patient is re-admitted after seven (7) days for an increase in propranolol dose to 1mg/kg/day in two divided doses. The same management process as above is to be followed. Note: The patient must not be given the morning dose of propranolol at home on the day of this admission. The dose change and increase in millilitres is to be clearly explained to parents before discharge home by the RMO or Paediatric Pharmacist. The Paediatric Pharmacist can be contacted to relabel the bottle of propranolol, or supply a new bottle if plicationsThere is a low risk of hypoglycaemia with use of propranolol (See Week 1 Protocol above for management if required). Parents are to be educated about the symptoms of hypoglycaemia (i.e. jitteriness, lethargy, sweatiness), and be provided with advice on how to respond (usually this will be giving a feed and seeking medical review for a BGL check if symptoms do not resolve promptly with feeding).Parents need to be aware that the risks of hypoglycaemia and/or hypotension are increased if the child is unwell, taking reduced feeds, and/or having vomiting/diarrhoea. Propranolol should be ceased if the infant develops a diarrhoeal or vomiting illness. If parents are concerned about their child in relation to possible side effects/complications, they should be instructed to contact the Paediatric or Dermatology Registrar via the hospital switchboard (business hours) or present to the Emergency Department (after hours).Back to Table of Contents Section 4 – Medical follow up post dischargeIt is important to ensure appropriate follow up has been organised prior to discharge home.Monitoring should occur initially at 2 weeks after starting propranolol and then approximately monthly or as per consultant. The patient should have regular (approximately monthly) weight checks by GP or treating specialist to increase propranolol dose accordingly if required.Patients under the care of a DermatologistEnsure a follow up appointment has been made in two weeks with the treating Dermatologist prior to discharge from PDSU.Patients under the care of an Ear, Nose, Throat (ENT) SurgeonEnsure a follow up appointment has been made with the ENT Surgeon involved in treatment prior to discharge from PDSU.Patients under the care of a PaediatricianEnsure a follow up appointment has been made with the treating Paediatrician prior to discharge from PDSU.Duration of Treatment and Cessation of therapyThe optimal treatment duration has not yet been established and is dependent on clinical response. Treatment periods can vary from 3 to 24 months. Evidence suggests propranolol may be stopped safely without the need for weaning the dosage however some specialists will prefer to wean the propranolol. If rebound growth occurs and is significant, consider restarting propranolol at the previous dosage.Back to Table of Contents Implementation This guideline will be:discussed at the Paediatric Clinical Governance and Resource Education Meeting;distributed to paediatric staff via email;distributed to dermatology staff via e-mail;Paediatric Unit medical and nursing staff are shown how to access documents on the Policy Register during orientation to the unit.Back to Table of ContentsRelated Policies, Procedures, Guidelines and LegislationPoliciesHealth Directorate Nursing and Midwifery Continuing Competence Policy Medication Handling PolicyProceduresCHHS Clinical Procedure – Vital Signs and Early Warning Scores Back to Table of ContentsReferencesDrolet BA et al.. Initiation and use of propranolol for infantile hemangioma: report of a consensus conference. Paediatrics. 2013; 1: 128-140.Price CJ et al.. Propranolol vs corticosteroids for infantile hemangiomas. A multicenter retrospective analysis. Archives of Dermatology. 2011; 147 (12): 1371-1376.Starship Children’s Health Clinical Guideline. Haemangioma – propranolol treatment. [Internet, last updated August 2015, date viewed October 2015] Available from - propranolol treatmentSouth Australia Paediatric Practice Guidelines. Propranolol for infantile haemangioma. [Internet, last updated October 2015, date viewed October 2015] Available from ? Nottingham Children’s Hospital. Propranolol for haemangiomas (over 3 months). [Internet, last updated September 2013, date viewed October 2015] Availble from SL et al.. Consensus statement for the treatment of infantile haemangiomas with propranolol. Australas J Dermatol, 2017; 58 (2): 155-159. doi:10.1111/ajd.12600Back to Table of ContentsDefinition of Terms PHACE syndrome: Is a cutaneous condition characterized by multiple congenital abnormalities - Posterior fossa malformations, Haemangiomas, Arterial anomalies, Cardiac defects, Sternal cleft and supraumbilical raphe syndrome.Back to Table of ContentsSearch Terms Haemangioma, Propranolol, Blood vessels, Dermatofibroma, IHBack to Table of ContentsDisclaimer: This document has been developed by Canberra Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Canberra Health Services assumes no responsibility whatsoever.Policy Team ONLY to complete the following:Date AmendedSection AmendedDivisional ApprovalFinal Approval 5 December 2018Entire documentED, WYCCHS Policy CommitteeThis document supersedes the following: Document NumberDocument NameCHHS16/125Propranolol for the Treatment of Infant Haemangiomas ................
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